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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12° Back to Search Results
Model Number WA22302D
Device Problems Break (1069); Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the resection electrode's loop was melted and broken.The issue occurred during a therapeutic hysteroscopic surgery.There was no delay.There were no reports of patient harm or injury.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Type of Device
HF-RESECTION ELECTRODE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18870714
MDR Text Key337267096
Report Number9610773-2024-00667
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051665
UDI-Public14042761051665
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K120418
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA22302D
Device Lot Number1000115044
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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